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Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain

Primary Purpose

Chronic Non-specific Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MANUAL THERAPY
THERAPEUTIC EXERCISE
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • People between 18 and 65 years of age
  • Neck pain of more than 3 months of evolution
  • Access and knowledge in the use of the internet
  • Complete the informed consent

Exclusion Criteria:

  • Previous trauma to the cervical region (such as whiplash)
  • Neck surgery
  • Osteoporosis
  • Arthritis
  • Cervical radiculopathy associated with externalized cervical hernia
  • Vertigo or vertebrobasilar insufficiency
  • Cancer
  • Vertebral fracture
  • Fibromyalgia
  • Cognitive impairment
  • Psychiatric disorders.

Sites / Locations

  • Cristina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual therapy and a telerehabilitation program

Manual therapy and recommendations for home exercises

Arm Description

In the experimental group, an intervention based on manual therapy and a telerehabilitation program based on exercises will be carried out. The investigators will apply manual therapy for ten minutes a week based on cervical mobilizations and suboccipital inhibitions. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.

In the control group, the same manual therapy intervention and recommendations for home exercises will be applied. This exercises recommendations will be based on a simulation of the exercise in the same session of the manual therapy of each week.

Outcomes

Primary Outcome Measures

Changes in disability
Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).

Secondary Outcome Measures

Changes in the health-related quality of life
Using the Short Form 12 Health Survey (SF-12). It is made up of a subset of 12 items from the SF-36 (physical function, social function, physical role, emotional role, mental health, vitality, bodily pain and general health), including 1-2 items from each of the 8 scales of the SF-36.
Changes in depression and anxiety
Using the Hospital Anxiety and Depression Scale (HADS). It consists of two series of seven questions (a total of 14 items), one represents the anxiety subscale and the other the depression. Each item is valued according to a four-point frequency scale that ranges from 0 to 3 (0 = I always do it; 1 = not so much; 2 = definitely not that much; 3 = not at all).
Changes in Kinesiophobia
Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia.
Changes in the pain: Visual Analog Scale (VAS)
Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10.
Adherence to treatment
Using a record book of the completion of the treatment program, where the activity carried out will be reflected.
Pressure pain threshold
Using a digital pressure algometer at a speed of 1 kg / cm2 / s perpendicular to the skin surface. The patient will be required to immediately indicate when the sensation of pressure (kg / cm2) becomes a sensation of pain, and thus terminate the compression.

Full Information

First Posted
April 7, 2021
Last Updated
November 1, 2022
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04841642
Brief Title
Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain
Official Title
Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality health service. The main objective of the study is to assess the change in disability produced by a telerehabilitation program (applied in the intervention group) in patients with chronic and nonspecific neck pain compared to the recommendation of home exercises (control group). The study that will be carried out will be a controlled and randomized clinical trial (ECCA), single-blind, longitudinal and prospective with two groups (intervention group and control group). The main study variables that are intended to be analyzed pre and post intervention are disability, quality of life, pain, adherence, and depression and anxiety. The study will take place between June 2020 and May 2021 in specialized physiotherapy clinics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy and a telerehabilitation program
Arm Type
Experimental
Arm Description
In the experimental group, an intervention based on manual therapy and a telerehabilitation program based on exercises will be carried out. The investigators will apply manual therapy for ten minutes a week based on cervical mobilizations and suboccipital inhibitions. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.
Arm Title
Manual therapy and recommendations for home exercises
Arm Type
Active Comparator
Arm Description
In the control group, the same manual therapy intervention and recommendations for home exercises will be applied. This exercises recommendations will be based on a simulation of the exercise in the same session of the manual therapy of each week.
Intervention Type
Other
Intervention Name(s)
MANUAL THERAPY
Intervention Description
The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.
Intervention Type
Other
Intervention Name(s)
THERAPEUTIC EXERCISE
Intervention Description
The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.
Primary Outcome Measure Information:
Title
Changes in disability
Description
Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).
Time Frame
Baseline, 8 weeks and 2 month after intervention.
Secondary Outcome Measure Information:
Title
Changes in the health-related quality of life
Description
Using the Short Form 12 Health Survey (SF-12). It is made up of a subset of 12 items from the SF-36 (physical function, social function, physical role, emotional role, mental health, vitality, bodily pain and general health), including 1-2 items from each of the 8 scales of the SF-36.
Time Frame
Baseline, 8 weeks and 2 month after intervention.
Title
Changes in depression and anxiety
Description
Using the Hospital Anxiety and Depression Scale (HADS). It consists of two series of seven questions (a total of 14 items), one represents the anxiety subscale and the other the depression. Each item is valued according to a four-point frequency scale that ranges from 0 to 3 (0 = I always do it; 1 = not so much; 2 = definitely not that much; 3 = not at all).
Time Frame
Baseline, 8 weeks and 2 month after intervention.
Title
Changes in Kinesiophobia
Description
Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia.
Time Frame
Baseline, 8 weeks and 2 month after intervention.
Title
Changes in the pain: Visual Analog Scale (VAS)
Description
Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10.
Time Frame
Baseline, 8 weeks and 2 month after intervention.
Title
Adherence to treatment
Description
Using a record book of the completion of the treatment program, where the activity carried out will be reflected.
Time Frame
At 4 and 8 weeks of treatment
Title
Pressure pain threshold
Description
Using a digital pressure algometer at a speed of 1 kg / cm2 / s perpendicular to the skin surface. The patient will be required to immediately indicate when the sensation of pressure (kg / cm2) becomes a sensation of pain, and thus terminate the compression.
Time Frame
Baseline, 8 weeks and 2 month after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People between 18 and 65 years of age Neck pain of more than 3 months of evolution Access and knowledge in the use of the internet Complete the informed consent Exclusion Criteria: Previous trauma to the cervical region (such as whiplash) Neck surgery Osteoporosis Arthritis Cervical radiculopathy associated with externalized cervical hernia Vertigo or vertebrobasilar insufficiency Cancer Vertebral fracture Fibromyalgia Cognitive impairment Psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso, PhD
Organizational Affiliation
University of Jaen
Official's Role
Study Director
Facility Information:
Facility Name
Cristina
City
Santa Brígida
State/Province
Las Palmas
ZIP/Postal Code
35308
Country
Spain

12. IPD Sharing Statement

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Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain

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